Academic Journal
Phase Ib/II trial of talimogene laherparepvec alone and with pembrolizumab in advanced solid tumors with liver metastases and hepatocellular carcinoma.
| Τίτλος: | Phase Ib/II trial of talimogene laherparepvec alone and with pembrolizumab in advanced solid tumors with liver metastases and hepatocellular carcinoma. |
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| Συγγραφείς: | Hecht, J.R., Oberoi, A., Garralda Cabanas, E., Jae Chon, H., Digklia, A., Rottey, S., Martin Jimenez, M., Chaney, M., Hippenmeyer, J., Lawrence, T., Liu, K., Hamidi, A., Chesney, J. |
| Έτος έκδοσης: | 2025 |
| Συλλογή: | Université de Lausanne (UNIL): Serval - Serveur académique lausannois |
| Θεματικοί όροι: | Humans, Liver Neoplasms/drug therapy, Liver Neoplasms/secondary, Carcinoma, Hepatocellular/drug therapy, Hepatocellular/pathology, Hepatocellular/therapy, Female, Antibodies, Monoclonal, Humanized/therapeutic use, Humanized/adverse effects, Male, Middle Aged, Aged, Adult, Biological Products/therapeutic use, Biological Products/administration & dosage, Antineoplastic Agents, Immunological/therapeutic use, Immunological/adverse effects, Immunological/pharmacology, 80 and over, Oncolytic Virotherapy/methods, Herpesvirus 1, Human, hepatocellular carcinoma, liver metastasis, pembrolizumab, solid tumor |
| Περιγραφή: | Newer effective therapies are needed for patients with solid tumors with liver metastases and unresectable hepatocellular carcinoma (HCC). Part 1 (dose exploration) evaluated intrahepatic talimogene laherparepvec (T-VEC) injection in group A (non-HCC liver metastases) and group B (HCC). Cohorts 1-4 received T-VEC monotherapy; cohorts 5 and 6 received T-VEC+pembrolizumab. Part 2 (dose expansion) evaluated intrahepatic or intratumoral T-VEC+pembrolizumab in non-HCC solid tumors. The primary endpoints were dose-limiting toxicities (DLTs) in part 1; objective response rate (ORR) per modified irRC-RECIST and safety in part 2. Part 1 enrolled 28 and 46 patients to receive T-VEC and T-VEC+pembrolizumab, respectively. Three patients reported DLTs (T-VEC, n = 2 grade 3 abdominal pain and aspartate transaminase increase; T-VEC+pembrolizumab, n = 1 grade 3 cholestatic hepatitis). ORR (secondary endpoint) with T-VEC was 0%; ORR (95% CI) with T-VEC+pembrolizumab was 8.3% (1.0, 27.0) for non-HCC and 13.6% (2.9, 34.9) for HCC. Part 2 enrolled 53 patients; ORR (95% CI) was 0% (0.0, 30.8)-20.0% (0.5, 71.6) across 5 tumor types, with 16.7% (95% CI: 3.6, 41.4) for triple-negative breast cancer with the largest sample size (n = 18). Safety findings were consistent with the therapies administered. Limited efficacy across tumor types evaluated limit further evaluation of intrahepatic T-VEC+pembrolizumab in this patient population. NCT02509507. |
| Τύπος εγγράφου: | article in journal/newspaper |
| Γλώσσα: | English |
| ISSN: | 1549-490X |
| Relation: | The Oncologist; https://iris.unil.ch/handle/iris/38230; serval:BIB_14A3EF9C1C3C |
| DOI: | 10.1093/oncolo/oyae203 |
| Διαθεσιμότητα: | https://iris.unil.ch/handle/iris/38230 https://doi.org/10.1093/oncolo/oyae203 |
| Αριθμός Καταχώρησης: | edsbas.8B3D0B6 |
| Βάση Δεδομένων: | BASE |
| ISSN: | 1549490X |
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| DOI: | 10.1093/oncolo/oyae203 |